Kornimate/medical-research-clean huggingface dataset:
difference in efficacy between stem cell transplantation and classical therapy in liver cirrhosis patients

Conditions: Liver Cirrhosis

Summary: the current treatment methods of liver cirrhosis are limited ,including antiviral therapy,supportive therapy and liver transplantation. antiviral therapy and supportive therapy especially the regularly intravenous infusions of plasma or albumin are combined in the clinical classical therapy treatment. in the other hand,umbilical cord mesenchyma stem cell with self and directed differentiation capacity can effectively rescue experimental liver failure and contribute to liver regeneration, which suggests the feasibility of stem cell transplantation therapy. in this study, the safety and efficacy of umbilical cord mesenchyma stem cell transplantation through interventional procedures and classical therapy in patients liver cirrhosis will be evaluated and compared.

this study will includ two research centers, the number of patients in transplantation group will be 30, the number of patients in classical therapy group will be 30. all the inclusion and exclusion criteria will be same and the data analysis will be complete by the epidemiological commissioner.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of liver cirrhosis; * without hepatic encephalopathy; * no ascites or have easily dissipated ascites; * value of bilirubin is less than 100; * value of albumin is greater than 16 g / l; * prothrombin time is less than 21 seconds; exclusion criteria: * severe cardiovascular disease, and immunocompromised patients; * patients with localized lesions affecting graft infection; * coagulation disorders; * liver nodules more than 2cm or liver cancer.

Keywords: umbilical cord mesenchyma stem cell liver cirrhosis antiviral therapy
pet/ct and bacterial/fungal pcr in high risk febrile neutropenia

Conditions: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Haematopoietic Stem Cell Transplant, Autologous; Haematopoietic Stem Cell Transplant, Allogeneic; Febrile Neutropenia

Summary: patients with acute leukaemia requiring induction or consolidation chemotherapy and those requiring a haematopoietic stem cell transplant are at high risk of fever and infection when they have low white cell counts (neutropenic fever). the causes of neutropenic fever are frequently unknown and patients are treated with broad antibiotics, without a clear target to what is being treated. this study will prospectively enroll patients who are receiving chemotherapy for acute leukaemia or for a stem cell transplant and compare the diagnostic utility of bacterial and fungal pcr performed directly off blood drawn, to the standard blood culture. patients who have persistent fever after 72 hours of antibiotics will then be randomized to have either the interventional scan (pet/ct) or the conventional scan (standard ct) to look for a source of infection. diagnostic yield, change in management and outcomes will be compared between arms.


Eligibility criteria:
inclusion criteria: * about to have an allogeneic haematopoietic stem cell transplant, or * about to have an autologous haematopoietic stem cell transplant, or * commencing induction or consolidation chemotherapy with curative intent for acute myeloid or acute lymphoid leukaemia exclusion criteria: * current actively diagnosed infection prior to transplant or chemotherapy * allergy to intravenous contrast for ct imaging * egfr \<30 * pregnant

Keywords: diagnosis
genotype-driven phase i study of irinotecan administered in neoadjuvant chemoradiotherapy in patients with stage ii/iii rectal cancer

Conditions: Rectal Cancer

Summary: irinotecan is one of effective drugs for colorectal cancer. in neoadjuvant chemoradiotherapy (crt), irinotecan is prescribed in a low dose of 50mg/m2/week because of toxicity. some current studies showed that irinotecan's dose can be increased significantly for those patients with 6/6 or 6/7 genotype of ugt1a1. therefore, the investigators designed this trial to explore the maximal tolerable dose (mtd) of irinotecan in combined neoadjuvant crt.


Eligibility criteria:
inclusion criteria: * patients with rectal adenocarcinoma * clinical staged t3/4 or any node-positive disease * age of 18-75 years * karnofsky performance status \> 80 * adequate bone marrow reserve, renal and hepatic functions * without previous antitumoural chemotherapy * no evidence of metastatic disease * written informed consent before randomization * ugt1a1's genotype of 6/6 or 6/7 exclusion criteria: * clinical staged i or iv * age of \ 75 years * karnofsky performance status \< 80 * previous pelvis radiotherapy * previous antitumoural chemotherapy * clinically significant internal disease * refuse to write informed consent before randomization * ugt1a1's genotype of 7/7

Keywords: neoadjuvant chemotherapy rectal cancer phase i study irinotecan
evaluation of the novel silq cleartract catheter in patients with chronic urinary retention

Conditions: Catheter Infection; Catheter Blockage; Catheter Related Complication; Catheter Calcification

Summary: to assess the ability of the silq cleartract™ 100% silicone 2-way foley catheter to reduce catheter associated complications in subjects that require a long-term indwelling foley catheter when compared to other commercially available foley catheters.

a prospective, randomized, multi-center, post-market study in subjects that require a long-term indwelling foley catheter. neurogenic bladder is commonly managed with indwelling catheters (urethral or suprapubic). indwelling catheters are associated with multiple complications, including recurrent urinary tract infections and catheter obstruction. a randomly assigned catheter will be inserted using standard techniques. the assigned catheters will either be the silq cleartract 100% silicone 2-way foley catheter or the current standard of care catheter. subjects will continue to use the assigned catheter for a period of approximately 3 months following regular standard of care. subjects will then be assigned the alternative catheter for an additional 3 month period after which they will be exited from the study the purpose of the study is to compare the incidence of catheter-related complications between the silq treated catheter and the current standard of care catheter(s). because these complications lead to more frequent interventions and associated treatment costs, the study will also calculate the economic impact of the use of silq treated catheters compared to standard of care catheters. patient-reported outcomes will also be measured via questionnaires upon each study visit. explanted catheter samples will also be sent to a core lab for quantification of the calcification present on the catheter surface.

Eligibility criteria:
inclusion criteria: * at least 18 years old * requirement of a 14 fr, 16fr, or 18fr indwelling urethral or suprapubic urinary catheter (for at least 6 months) for bladder drainage. * able and willing to comply with study procedures * able and willing to give informed consent. exclusion criteria: * history of reconstructive bladder surgery such as bladder augmentation or continent catheterizable stoma. * cognitive deficit limiting the ability to respond to clinical questionnaires. * allergy or sensitivity to any catheter material used in this study.
clinical trial to evaluate safety and efficacy of jalosome® soothing gel.

Conditions: Radiation-induced Dermatitis

Summary: primary objective - to investigate the effectiveness of jalosome® compared with placebo in the prevention and treatment of rid in patients with hnc undergoing rt. secondary objectives: * to investigate the effectiveness of jalosome® in reducing the maximum severity of rid compared with placebo. * to investigate the effect of jalosome®, compared with placebo, on patients' quality of life. * to investigate safety and tolerability of jalosome®. * to investigate patient's compliance to jalosome® treatment. * to investigate patient's global satisfaction with jalosome® treatment.

primary endpoint: * mean time difference in development of g2 rid (according to ctca) between jalosome® and placebo arms. a median difference of at least 7 days is considered of clinical significance. • secondary endpoints: * proportion of subjects without g2 rid at the end of rt, in the jalosome® and placebo arms. * proportion of subjects without g2 rid at different timepoints (week 5, week 6 and two weeks after the last radiation) in the jalosome® and placebo arms. * worst skin toxicity during treatment and up to 2 weeks after the last radiation, according to ctcae, in the jalosome® and placebo arms. * rid grade (mean and worst) on the risras scale, assessed weekly, in the jalosome® and placebo arms. * mean and worst score of pro-skindex-16 questionnaire performed weekly, in the jalosome® and placebo arms. * mean pain measured by the 11-point nrs of the brief pain inventory (bpi), as reported in patients' diary (daily) and assessed during visits (weekly), in the jalosome® and placebo arms. * patient's compliance to jalosome® treatment. * patient's global satisfaction with jalosome® treatment. * jalosome® overall safety and tolerability. study design: monocentric, randomized, double-blind, placebo controlled clinical trial.

Eligibility criteria:
inclusion criteria: * male and female subject aged ≥18 years old. * performance status 0-1. * diagnosis of hnc (epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinuses or salivary glands). * postoperative or curative rt (total radiation dose of at least 60 gy), with or without concurrent chemotherapy. * willingness and ability to give informed consent and comply with study procedures. exclusion criteria: * pregnant or lactating women. * previous rt on the head and neck area. * planned to receive concurrent cetuximab. * cutaneous and/or connective diseases (i.e. lupus erythematosus or scleroderma). * systemic diseases known to delay the skin healing process, such as diabetes mellitus or severe renal failure. * use of a tissue-equivalent bolus. * use of over-the-counter topical medications containing steroids. * presence of rashes or unhealed wounds in the radiation field. * recent sun exposure (\<1 month). * mental conditions that could adversely affect subject's adherence to the study.
multicenter hologic tomosynthesis study

Conditions: Breast Cancer

Summary: the purpose of this image acquisition study is to compare, in a reader study, the performance of tomosynthesis (3d) to (2d ffdm) conventional images in an enriched retrospective reader study. synthetic 2d images, generated from the tomosynthesis image, will be available to the readers to provide an over view of the anatomy similar to a scout view in ct imaging and to determine whether the 3-d images with the synthesized 2d overview are non-inferior to the 2-d images alone as determined by receiver operating characteristic (roc) area under the curve.


Eligibility criteria:
inclusion criteria: * female * any ethnic origin * no contraindication of routine bilateral mammography exclusion criteria: * any contraindications to mammographic screening, including but not limited to: * significant existing breast trauma * pregnancy * lactating * previous surgical biopsy * previous breast cancer * placement of an internal breast marker * breast implants * unable to understand and execute written informed consent * breasts are too large to be imaged on the 24 cm by 29 cm detector with a single exposure

Keywords: breast cancer breast cancer screening
comparing the efficacy of surgery staging and image staging of locally advanced cervical cancer

Conditions: Locally Advanced Cervical Cancer

Summary: the study is a domestic multicenter, prospective, non-randomized controlled concurrent trial. it will be assessed whether surgery staging on locally advanced cervical cancer is superior to image staging for improving progression-free survival and overall survival.

all eligible patients will be divided into the following two treatment groups nonrandomly. image staging group: standard chemoradiation (pelvic ebrt/extended-field ebrt + concurrent platinum-containing chemotherapy+brachytherapy). surgery staging group: open/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation. (level of lymph node dissection: at least the inferior mesenteric artery. chemoradiation will be conducted within 28 days postoperatively.)

Eligibility criteria:
inclusion criteria: 1. the patients with good compliance, voluntarily signed the informed consent form and participated in the study. 2. histopathology: squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma 3. stage (figo2018): ib3, iia2, iib-iva; 4. ecog score: 0 \~ 1; 5. the expected survival \>6 months; 6. the result of a pregnancy test (serum or urine) within seven days must be negative for women of childbearing age, who must take contraception during the trial. exclusion criteria: 1. activity or uncontrol severe infection; 2. liver cirrhosis or other decompensated liver disease; 3. a history of immune deficiency, including hiv positive or a congenital immunodeficiency disease; 4. chronic renal insufficiency or renal failure; 5. other malignancies were diagnosed within five years or needed treatments; 6. myocardial infarction, severe arrhythmia and congestive heart failure with grade ≥2 (new york heart association); 7. the ct/mri/pet/ct show that the para-aortic lymph nodes are positive; 8. a history of pelvic artery embolization; 9. a history of pelvic radiotherapy; 10. a history of partial hysterectomy or radical hysterectomy; 11. a history of severe allergic reaction to platinum drugs; 12. the drugs for the treatment of concomitant disease seriously impaired liver or kidney function, such as tuberculosis; 13. patients who cannot understand the research regimen and refuse to sign the informed consent form; 14. other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.

Keywords: surgery staging image staging locally advanced cervical cancer pfs
a study to evaluate karxt as a treatment for psychosis associated with alzheimer's disease (adept-4)

Conditions: Alzheimer Disease

Summary: the purpose of this study is to evaluate the safety and efficacy of karxt in adult participants with mild to severe alzheimer's disease (ad) with moderate to severe psychosis related to ad.


Eligibility criteria:
inclusion criteria * patients who are 55 to 90 years of age, inclusive, at the time of screening (visit 1). * patients who are diagnosed with ad based on the 2024 national institute on aging - alzheimer's association criteria with ad biomarker confirmation. * patient must have a magnetic resonance imaging (mri) or computed tomography (ct) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (cns) disease that could account for the dementia syndrome, eg, major stroke, neoplasm, subdural hematoma. * patient must have a history of psychotic symptoms (meeting international psychogeriatric association criteria) for at least 2 months prior to screening (visit 1) (participants may or may not have symptoms of agitation). exclusion criteria - patients will not be able to participate if they have:. i) psychotic symptoms that are primarily attributable to a condition other than the ad causing the dementia, eg, schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features. ii) history of major depressive episode with psychotic features during the 12 months prior to screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder. iii) patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: alzheimer's disease ad adept4 adept-4 karxt psychosis
wound necrosis in lower extremity surgery

Conditions: Extremity Lower Wounds

Summary: researchers are performing this study to evaluate if intraoperative angiography can be shown numerically to determine which wounds are at high risk of wound necrosis/breakdown.

at the beginning of the participants surgical procedure, a picture will be obtained using intraoperative angiography using icg dye which the camera can detect. this dye will be provided through intravenous access. the picture will be taken of the wound to determine preoperative blood flow to the area where the incision is planned. after the wound has been closed postoperatively, a final picture, using the procedure described above, will be taken to determine blood flow after closure of the wound. these images will be obtained using intraoperative angiography. the participant will be followed after the surgical procedure at standard intervals as determined by the surgeon until the wound heals or requires further intervention.

Eligibility criteria:
inclusion criteria: -surgical indication for high risk lower extremity surgery exclusion criteria: * previous high risk lower extremity surgery * revision high risk lower extremity surgery * traumatic amputation * active infection of any kind or chronic infection with hiv, hepatitis c, or syphilis

Keywords: amputation necrosis high risk lower extremity wound
a comparative study between the efficacy of diode laser and nano-chitosan gel on activation of non-vital in- office bleaching agent

Conditions: Tooth Discoloration

Summary: the growing demand for white smile between patients has increased over recent years, the development of techniques and improvement of materials permits searching for beautiful natural smile. the discoloration of teeth might be intrinsic, extrinsic, or combined. a variety of commercial bleaching agents is available. the most common substances used are carbamide peroxide or hydrogen peroxide or a mixture of sodium perborate and hydrogen peroxide.

the aim of the study is to assess the effectiveness of two different in-office bleaching materials carbamide peroxide alone and carbamide peroxide with chitosan nanoparticles using diode laser as an activator regarding tooth whitening and color stability 1 day , 1 weeks, 1 month after treatment using vita easy shade.

Eligibility criteria:
inclusion criteria: * discolored crown, non-vital or endodontically treated upper central and lateral incisors * previous endodontic treatment performed two or more years earlier. exclusion criteria: * caries on upper central and lateral incisors, inadequate fillings, and progressive periodontal disease.

Keywords: chitosan nanoparticles diode laser carbamide peroxide nonvital teeth bleaching
phone-based smoking cessation intervention for patients with chronic pancreatitis.(start)

Conditions: Pancreatitis, Chronic

Summary: this study aims to explore whether regular telephone intervention in patients with chronic pancreatitis can improve their smoking cessation rate.

chronic pancreatitis（cp） is a chronically progressive disease characterized by pancreatic fibrosis and inflammation, and its basic pathological features include chronic inflammatory damage to the pancreatic parenchyma, interstitial fibrosis, pancreatic parenchymal calcification, pancreatic duct dilation, and pancreatic duct stones. environmental factors such as alcoholism，smoking and genetic factors are the main causative factors of cp. clinical studies have found that smoking can not only accelerate the course of cp, but also increase the risk of cp-related complications. some scholars believe that smoking cessation may be a potential way to prevent the progression of cp and improve the prognosis of cp. although there is no evidence to verify whether smoking cessation will improve the clinical course of cp, the latest acg clinical guideline strongly recommends cp patients quit smoking. in 2016，a prospective study of smoking cessation interventions in cp patients showed that 27 enrolled patients had a smoking cessation rate of 0% after 6 months of smoking cessation intervention, indicating that smoking cessation is a huge challenge for cp patients. the investigators propose to conduct a randomized controlled trial to investigate the effects of telephone intervention on smoking cessation in patients with cp and explore the impact of smoking cessation on their clinical course and prognosis.

Eligibility criteria:
inclusion criteria: 1.18 years of age and older living; 2.patients diagnosed as chronic pancreatitis; 3.self-reported smoking ≥ 5 cigarettes; 4.urine cotinine levels ≥ 200 ng/ml; 5.owning a phone; 6.willing to provide informed consent to participate in the study. exclusion criteria: 1. patients diagnosed as pancreatic cancer within 2 years after diagnosing chronic pancreatitis; patients diagnosed as groove pancreatitis or autoimmune pancreatitis; 2. pregnant or lactating women; 3. patients with life expectancy ≤ 12 months; 4. comorbidities such as alzheimer's disease, end-stage cancer, hiv, end-stage congestive heart failure, end-stage chronic obstructive pulmonary disease, uncompensated cirrhosis, renal failure; 5. smoking e-cigarettes or other forms of non-burning tobacco. 6. patients refused to participate.

Keywords: smoking cessation phone-based intervention
impact of cerebellar tms on brain and cognitive functions in schizophrenia: a pilot study

Conditions: Schizophrenia; Cerebellar Function; Condition

Summary: this is a single-site, sham-controlled, randomized trial in a total of 60 subjects between ages 18 and 40 years with schizophrenia. this study will investigate the effects of 4-week rtms treatment on brain and cognitive functions in patients. subjects will be randomized to one of the following arms: arm 1: standard of care (soc) and active rtms arm 2: standard of care (soc) and sham rtms each participant will receive rtms five days per week, for four consecutive weeks. functional magnetic resonance imaging (fmri) scans, clinical assessments, and cognitive tests will be performed at baseline, end of the 2nd week, and end of the 4th week.


Eligibility criteria:
inclusion criteria: 1. male or female subjects 18 to 40 years of age 2. dsm-v diagnosis of schizophrenia spectrum disorders 3. competent to provide informed consent exclusion criteria: 1. lifetime dsm-v diagnosis of an axis-i disorder other than schizophrenia spectrum disorders 2. lifetime diagnosis of ataxia or other cerebellar disorders 3. lifetime diagnosis of mental retardation, dementia, alzheimer's disease, parkinson's disease, huntington's disease, or other neurodegenerative disorders 4. any active general medical condition or cns disease which can affect cognition or response to treatment 5. substance dependence or abuse in the past six months 6. seizure history 7. tms within three months or ect within six months 8. pregnancy as indicated by self-report 9. mri contraindications